Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

NCT04807894 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 702576
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections. The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown. The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.

Conditions

Recurrent Urinary Tract Infection; Vaginal Atrophy; Postmenopausal Disorder

Keywords

urinary tract infections,; postmenopausal women; vaginal atrophy,; vaginal flora

Outcome Measures

Primary Outcomes (6)

• To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.

  Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 1 month to check for presence of UTI.

  1 month

• To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.

  Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 4.5 months to check for presence of UTI.

  4.5 months

• To assess whether topical vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections.

  Patients will receive months phone calls to assess for symptoms of UTI and urine will be collected in study visits at 9 months to check for presence of UTI.

  9 months

• To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.

  The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 1 month to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  1 month

• To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.

  The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 4.5 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  4.5 months

• To determine whether topically applied vaginal testosterone cream is more effective than placebo cream in changing vaginal flora and pH in postmenopausal women with recurrent urinary tract infections.

  The vaginal pH, vaginal atrophy score, and vaginal swabs for participants will be collected at 9 months to assess whether there is improvement in pH and vaginal atrophy scores as well as normalization of vaginal flora.

  9 months

Study Arms (2)

Vaginal Testosterone Cream Arm

EXPERIMENTAL

Women enrolled in this arm will receive vaginal testosterone cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.

Drug: Vaginal Cream with Applicator

Vaginal Placebo Cream Arm

PLACEBO COMPARATOR

Women enrolled in this arm will receive vaginal placebo cream to be applied once each night for two weeks followed by twice-weekly applications for a total duration of nine months.

Drug: Vaginal Cream with Applicator

Interventions

Vaginal Cream with Applicator DRUG

Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.

Also known as: Testosterone Cream

Vaginal Placebo Cream Arm; Vaginal Testosterone Cream Arm

Eligibility Criteria

• Age: 60 Years - 90 Years
• Gender Eligibility Details: Study is aimed at postmenopausal women with history of recurrent UTIs.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yo Female
• Postmenopausal
• Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).
• English Proficiency
• Unable or unwilling to use topical estrogen.
• Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.
• Patient on oral estrogen therapy may be included.
• Patient with slings, prior vaginal surgery or pessary may be included.

You may not qualify if:

• Current UTI/ Dipstick and culture positive (\> trace leukocytes or nitrites)
• Antibiotic (vaginal or oral) use in the last 4 weeks
• Current sexually transmitted infection
• Chronic Foley catheter use or chronic ureteral stent placement.
• Vaginal probiotic use in the last 4 weeks
• Patient currently using vaginal estrogen.
• Post-void Residual Volume \>150 mL or current diagnosis of urinary retention
• Non-evaluated hematuria (\> trace on dipstick, microscopic, gross)
• Unable to complete study tasks or comply with follow up.

Sponsors & Collaborators

• Maimonides Medical Center: lead
• American Urological Association: collaborator

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Central Study Contacts

Alison Polland, MD

CONTACT

(718) 283-7770; apolland@maimonidesmed.org

Mariela Martinez, MD

CONTACT

mmrivera@maimonidesmed.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: March 19, 2021
• Study Start: November 1, 2020
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)